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Understanding and Implementing a Quality by Design Program
- Using Models
- Risk Assessment
- Control Strategy
- Design of Experiments
- FMEA and Control Plan
- Developing a Design Space
- Target Operational Profile
- Process Analytical Technology (PAT)
- Quality Target Product Profile (QTPP)
Overview of the webinar
- Understand what is meant by Quality by Design
- Understand the benefits from applying a QbD approach
- Provide key steps to implement a QbD program
- Understand what the important tools used to implement a QbD approach
Who should attend?
- Process owners
- Quality auditors
- Quality engineers
- Quality professionals
- Production engineers
- Production supervisors
- Senior quality managers
- Regulatory professionals
- Manufacturing engineers
- Compliance professionals
- Development professionals
- Senior development managers
Why should you attend?
- This training will explain the main principles behind a QbD approach and provide guidelines in how to implement the concepts into a pharmaceutical development organization
- Topics covered will include the target product quality profile, risk assessment, methods to establish a design space, and design of a control strategy
- The review will help bridge the gap between understanding the principles and practical application
- Implementing these principles into the pharmaceutical development culture can be challenging
- QbD involves a complex set of interactions, technologies and systems that are not easy to grasp
- The benefits of applying the QbD principles in the pharmaceutical industry have been well advertised, most important are the direct benefits to our primary customer, the patient
- Application of these principles can also benefit the pharmaceutical companies by improving manufacturing efficiency and promoting innovation
- Per Janet Woodcock M.D. Director, Center for Drug Evaluation and Research (CDER), Food and Drug Administration “All products are designed and developed to be of high quality; QbD provides a structured framework for developing, documenting and presenting development rationale, experience and knowledge of the formulation and the process, and to ensure manufacture of products consistently fit for patient use”
Faculty - Mr.Steven Laurenz
Steven Laurenz, Principal Consultant – BioPhia Consulting Inc., has over 25 years of technical leadership experience in product development, process development, technology transfer, and process optimization. He is skilled in taking new products from early laboratory stage to successful manufacturing launch. He is an expert in integrating Quality by Design and risk management into product development. He has proven experience in establishing a Quality System for a R&D Quality Assurance organization. Steven has headed product development departments at Abbott Laboratories and AbbVie Inc. and held leadership positions in numerous technical consortium. Steven Laurenz holds an M.S. in Chemical Engineering from the Michigan State University.